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Frequently Asked Questions

Reference: TGA

I have been asked by a patient to prescribe an unapproved medicinal cannabis product. Do I have an obligation to prescribe it?

The responsibility and decision to prescribe any therapeutic good, including unapproved products rests with the prescriber. You have the right to decline to prescribe a medicinal cannabis product if you believe there is insufficient clinical justification or evidence to support the safe and effective use of the product.

The prescriber and patient (or patient's parents or guardian) through informed consent accept responsibility for any adverse consequence of therapy using an unapproved medicinal cannabis product.

I would like to prescribe a medicinal cannabis product, what access pathway should I use?

There are a number of mechanisms to enable access to ‘unapproved’ medicinal cannabis products including
- access for individual patients through:
   - AP scheme
   - SAS-B or
   - access as part of a clinical trial.

How do I submit an SAS application for an ‘unapproved’ medicinal cannabis product?

As of 30 July 2018 an online system was introduced to enable the submission of SAS applications and notifications electronically. The TGA has collaborated with state and territory health departments to streamline the application process for access to unapproved medicinal cannabis products in Australia.
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The SAS online system allows prescribers in certain states and territories to submit an application to both the Commonwealth and the relevant state or territory health department simultaneously.

Further information on the SAS online system and details on the submission of medicinal cannabis applications can be found via the TGA’s Special Access Scheme online system.

Standard SAS forms can be used as required and are available on the SAS webpage. If using these application forms, a separate application to the relevant state or territory health department may be necessary. All prescribers are strongly encouraged to be aware of any state or territory requirements prior to prescribing ‘unapproved’ medicinal cannabis products.

How do I submit an Authorised Prescriber application form?

The standard forms are available on the Authorised Prescriber page. Follow this link for further information.

Will the TGA allow me to access only one particular product?

No. Any ‘unapproved’ medicinal cannabis product can potentially be accessed under the SAS or AP scheme. It’s the responsibility of the prescriber to specify which product they wish to access. The TGA does not maintain a list of ‘unapproved’ medicinal cannabis products.

Are there specific medical conditions for which the TGA will allow access to medicinal cannabis?

No. It is the responsibility of the prescriber to determine whether the specific product is suitable for the condition being treated based on clinical justification and where all existing approved medicines have failed. The TGA has published guidance documents that prescribers may find useful when considering treatment with medicinal cannabis. Follow this link for further information.

Do I need both TGA (Commonwealth) and state or territory approval to use medicinal cannabis?

Depending on the state, both Commonwealth and state or territory approval is required. Prescribers should confirm local requirements with their state or territory health department.

What level of clinical evidence is required to support an application to access medicinal cannabis for my patient?

The patient's medical history and condition must be reviewed where existing approved treatments have failed. The efficacy and safety data submitted in support of the application should be weighed against the seriousness of the condition. Please also include details of intended monitoring of the patient once treatment commences. Please see the SAS guidance for health practitioners and sponsors for more detailed information about what information to include in a SAS application, or follow this link.

Does the TGA publish a list of Authorised Prescribers?

For privacy reasons, the TGA does not publish a list of Authorised Prescribers who have been authorised to supply medicinal cannabis products under the Therapeutic Goods Act 1989.

Furthermore, in Australia doctors are not allowed to advertise to the public that they are able to prescribe a particular medicine. This is not just a matter relating to the Therapeutic Goods legislation, but also to the standards upheld by the Australian Health Practitioner Regulation Agency and the Medical Board of Australia and goes to matters of medical ethics and good medical practice.

The TGA has approved or authorised my application to become an Authorised Prescriber but the state or territory has not granted me the necessary approval to treat a named patient with the product I have been authorised to supply. Can I still use the product on the named patient?

No. Authorisation from the TGA to supply a specific medicinal cannabis product to treat a class of patients does not override any state or territory requirements.

What is the relevance of the Standard for Medicinal Cannabis (TGO No. 93)?

Compliance with this standard provides an assurance to the medical practitioner that the product they intend to prescribe to their patients meets a high standard of quality, consistent with what is expected of a pharmaceutical-grade product.

Am I required to complete the form declaring that the medicinal cannabis product conforms with the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017?

No. The sponsor or manufacturer should complete this form and submit it to the TGA directly or to you for you to submit to the TGA as supporting documentation for your SAS-B or AP application.

Does the TGA charge a fee to process my notification or application to access medicinal cannabis products through the SAS or the AP scheme?

No.

I have submitted a notification through SAS (Category A) or obtained authorisation to supply the ‘unapproved’ medicinal cannabis product through the SAS (Category B) or AP scheme. What if the sponsor of the goods will not supply it?

A sponsor is under no obligation to supply an ‘unapproved’ product merely because it has been notified to, approved or authorised under the SAS or the AP scheme.

Before making a notification or application to the TGA, you might want to contact the sponsor to ensure that they will agree to supply the product once appropriate approvals are received.

Contact

For further information or for other medical inquiries, please reach out to us by emailing hi@kind.com.au.

Kind Medical acknowledges the Traditional Custodians of country throughout Australia and their connections to land, sea and community. We pay our respect to their Elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today.

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